MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. 2008T HEMODIALYSIS SYS., WITH CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	190713
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A user facility clinical manager (cm) reported that a dialyzer blood leak occurred during a patient¿s hemodialysis (hd) treatment.The blood leak occurred towards the end of the treatment.The blood leak was internal, and it was confirmed to be visually observed.Leading up to the event, the 2008t machine was alarming nonstop with elevated venous pressure and transmembrane pressure (tmp) alarms.However, the machine did not give a blood leak alarm.A blood leak test strip was not used, as it was deemed unnecessary.There was no physical damage or defect noted on the dialyzer.Fresenius bloodlines were also being used for the treatment.After the leak was noted, the blood pump was stopped.It was documented in the patient safety event report that they attempted to return the patient¿s blood and were unsuccessful.The patient¿s blood was not returned; estimated blood loss (ebl) was 300 ml.The cm confirmed there was no patient serious injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient did not undergo any additional treatment.The machine was not removed from service for evaluation.The cm said they continued using the machine and have not experienced any further issues with the device.
Event or Problem Description
A user facility clinical manager (cm) reported that a dialyzer blood leak occurred during a patient¿s hemodialysis (hd) treatment.The blood leak occurred towards the end of the treatment.The blood leak was internal, and it was confirmed to be visually observed.Leading up to the event, the 2008t machine was alarming nonstop with elevated venous pressure and transmembrane pressure (tmp) alarms.However, the machine did not give a blood leak alarm.A blood leak test strip was not used, as it was deemed unnecessary.There was no physical damage or defect noted on the dialyzer.Fresenius bloodlines were also being used for the treatment.After the leak was noted, the blood pump was stopped.It was documented in the patient safety event report that they attempted to return the patient¿s blood and were unsuccessful.The patient¿s blood was not returned; estimated blood loss (ebl) was 300 ml.The cm confirmed there was no patient serious injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient did not undergo any additional treatment.The machine was not removed from service for evaluation.The cm said they continued using the machine and have not experienced any further issues with the device.
Additional Manufacturer Narrative
An engineering and risk-based evaluation of the event was performed.The primary risk control measures in the machine are minor and major blood leak alarms.The minor blood leak and major blood leak alarms trigger an audible and visual alarm, and the major blood leak alarm also triggers a stop to the blood pump and a clamp applied to the venous return line, which stops blood circuit flow and ultrafiltration.A secondary risk control is the alarms test, included in the 2008t machine operational manual as a pre-treatment machine setup test to be conducted by the user prior to patient treatment.The instructions provide multiple methods to perform the self-test, which confirms functionality of multiple alarms, relevant for this investigation, it specifically includes a verification that the blood leak alarm sensor is operating.In addition, the device history record (dhr) was reviewed and specific tests during test & calibration, final test, the alarm override function was operating correctly and the self-test check was operating correctly.The design controls, design verification, and individual machine testing conducted by both fresenius and the clinic show no evidence that the machine failed to perform as intended.Based on the engineering and risk-based evaluation of the events reported within the complaint(s), it has been concluded no device malfunction, nonconformance, or systemic quality issue was identified.The 2008t machine/system was concluded to be performing as designed with respect to blood leaks into the dialysate not triggering the blood leak alarms, major or minor.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; director, quality systems; 900 w zaragosa drive suite d; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 23149706
• Report Number: 0008030665-2025-02289
• Device Sequence Number: 9910238
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K150708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2025
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS BLOODLINES.; FRESENIUS BLOODLINES.; FRESENIUS OPTIFLUX DIALYZER.; FRESENIUS OPTIFLUX DIALYZER.
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 52 KG